Medical Device Equipment, Electrical Safety & Compliance Assessment

As medical electrical (ME) devices and systems continue to become more intricate and sophisticated, the relevant regulatory requirements and applicable standards for assessing patient safety in these devices have evolved as well. Anticipating potential hazards and risks, as well as implementing mitigation strategies to minimize the level of possible harm from ME devices, requires several components; including an interdisciplinary team of experts who are involved in device design and development, health care professionals who are involved in device clinical use and application, and ultimately patients who have, when applicable, their own device experience.

Technical Standards for Assessing the Basic Safety and Essential Performance of Medical Electrical Equipment and Systems

The International Electrotechnical Commission (IEC) has produced technical standards for assessing the basic safety of Medical Electrical (ME) equipment and systems, called IEC 60601, that are internationally accepted and should be followed by medical device manufacturers to comply with regulatory bodies worldwide. Compliance with the latest edition of the base of this set of standards, IEC 60601-1:2005, 3rd edition, Amendment 1, and its other relevant parts is critical for introducing new medical devices to market in a timely manner.  For example, as of January 1, 2014, the U.S. FDA required new submissions for ME devices via 510(k) and PMA to demonstrate conformity to this standard.

Effective Handling of Risk Management (RM) and Essential Performance Services

A new and significant requirement for compliance, as specified by IEC 60601-1 3rd edition and ISO 14971: 2007, is the effective handling of risk management (RM) and essential performance (EP).  Failure to handle these areas can delay the certification process.  Resources and expertise should be devoted during the early stages of device design to ensure that potential risks have been minimized as much as possible and that device validation and testing generates sufficient RM and EP files for regulatory compliance. It is noted that standards and guidance documents are designed to support compliance with 21 CFR 820 Quality System Regulation (US) and 93/42/EEC Medical Device Directives (EU) but are not designed to replace them.

Services

Exponent consultants often assist clients with their device design verification and validation process. Clear design and development plans and well-defined design inputs are essential to an efficient design process.  However, many devices fail to make it through the validation stage, when product design changes may have major schedule, resource, and expense ramifications that could impact project success. Exponent engineers are highly experienced in all aspects of the device design procedure, including areas such as design verification, device usability studies, electrical medical equipment configuration, and laboratory testing.

Exponent can provide engineering expertise early in the medical device product development process.  We have routinely provided services related to areas such as:


  • The testing of medical devices, accessory components, and power management (e.g., Lithium battery packs).  
  • Support to ME equipment manufacturers in implementing IEC60601 standards and preparing for an efficient and effective certification process. 
  • Support in all phases of ME equipment and system life-cycle, including early design assistance. 
  • Establishing general requirements for risk management, such as hazard identification, risk acceptability criteria, as well as pre- and post-production risk analysis.
  • Assistance to medical device manufacturers in determining the root-cause of failures.
  • Support in remediation activities to correct deficiencies and guidance through electromagnetic compliance (EMC) re-qualification of their products.

Professionals

Knowledge